Diagnostic yield of ssRAB combined with CBCT imaging in comparison with CBCT-based navigation bronchoscopy using a passive catheter-based approach: preliminary results

<bold>Objective:</bold> The Ion Endoluminal System with an actively steerable catheter and shape sensing technology can navigate to peripheral airways to potentially improve biopsy sampling for small peripheral nodules (PPN). Our objective is to evaluate if shape sensing robotic-assisted bronchoscopy combined with CBCT (ssRAB+CBCT) improves diagnostic yield compared to CBCT guided navigation bronchoscopy alone using passive manual extended working channels (CBCT-NB). <bold>Method:</bold> This single center study will enroll 131 patients, we present preliminary results. The primary outcome is diagnostic yield, secondary endpoints include tool in nodule (TIN), procedure time and safety. A fixed CBCT system was used for 3D-Imaging with augmented fluoroscopy as needed to reach the target nodule prior to biopsy or when refining position. Rapid onsite evaluation of the biopsied material was routinely used. <bold>Results:</bold> In our first 38 patients 47 PPN were biopsied using ssRAB+CBCT with median size 14mm; mean 6 airway generations out; 29% positive bronchus sign. Target nodule diagnostic yield (strict) was 89,5% compared 76,4% for CBCT-NB alone in our local cohort (n=208, intermediate definition). TIN was confirmed with CBCT or ROSE with augmented fluoroscopy in a total of 89,5% for the primary target lesion. Mean ssRAB+CBCT procedure time was 42 min for patients with only 1 target nodule (overall range 21-118 min). There were no SAE or PTX requiring chest tube. <bold>Conclusion:</bold> ssRAB+CBCT has the potential for higher diagnostic yield. When inclusion is completed, a propensity score matched analysis will compare ssRAB+CBCT to our currently standard of care CBCT-NB.